brand name | preparation | manufacturer | route | form | dosage^ | cost* |
Abelcet | Amphotericin B lipid complex (ABLC) | Sigma Tau Pharm. | IV | vial | 100 mg (5mg/mL 20 mL) | $6.30 per mL |
*Prices represent cost per unit specified, are representative of "Average Wholesale Price" (AWP).
^Dosage is indicated in mg unless otherwise noted.
Not removed in dialysis, no supplement needed post HD. Usual dose.
Usual dose.
No data.
No renal dosage adjustment in patients with renal insufficiency.
Includes Aspergillus spp (A. fumigatus, A. flavus), Candida spp. (C. albicans, C. krusei, C. parapsilosis, C. tropicalis), Cryptococcus neoformans, and Blastomyces dermatitidis.
Active against most fungi with the notable exceptions of Candida lusitaniae, Trichosporon beigelii, Aspergillus terreus (some isolates), Pseudallescheria boydii, Scedosporium prolificans, Malassezia furfur and many Fusarium spp.
Amphotericin binds to ergosterol in the fungal cell membrane, resulting in the disruption of the cell membrane. As a result, the cell membrane can no longer function as a selective barrier and leakage of intracellular contents occur. The lipid formulations are designed to reduce the binding of amphotericin to mammalian cell membranes, reducing toxicities.
Not absorbed from the GI tract.
Slow renal excretion. Approximately 0.9% of the dose was excreted on the first day.
No data.
0.9-2.5 mcg/ml after 5mg/kg IV dose administration.
7.2 days
It attains lower serum concentration but has a greater distribution volume than conventional amphotericin. Increased uptake by the liver and spleen and decreased kidney concentration. Poor fat distribution (animal data).
No data.
B- There are limited data on the use of Amphotericin B lipid complex in pregnancy; therefore, the use should be limited to patients where the benefit outweighs the risk.
No data are available.
Comment: Abelcet dosed at 2.5-5 mg/kg/day is recommended in neonates to treat invasive candidiasis.
Comment: This is a prospective, randomized trial comparing the safety and efficacy of Abelcet vs. Ambisome for the treatment of suspected or documented fungal infections in 82 patients with leukemia. The overall response to therapy was 27/43 (63%) for Abelcet and 15/39 (39%) for Ambisome (p=0.03). It is important to note that patients in the Ambisome arm were sicker (i.e., more with Fusarium spp .). Patients receiving Abelcet had more infusion-related toxicity, whereas patients receiving Ambisome had a higher incidence of bilirubin elevation.
Comment: In this prospective, randomized trial, nephrotoxicity (3x above baseline) was noted in 6.2% and 26.9% of patients receiving Ambisome and Abelcet, respectively (p< 0.001). Chills and rigors were reported in 50.5% of the Abelcet arm and 24.3% in the Ambisome arm(p< 0.001)). Ambisome, at a higher cost, has a lower incidence of nephrotoxicity and infusion-related toxicity. Interestingly, ADR reported with Abelcet in this trial is 2-fold higher than historical rates.
Comment: Abelcet at a dosage of 5 mg/kg/day was well tolerated in 111 pediatric patients enrolled in this open-label compassionate use protocol.
Comment: Clinical improvement occurred in 86% of patients treated with Abelcet, even though CSF sterilization was achieved in 42% after 2 weeks of therapy. This small study suggests that there may be a role for Abelcet in the treatment of cryptococcal meningitis. However, larger trials need to be conducted.